UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013052
Receipt number R000015183
Scientific Title Clinical study using samples of patients experienced systemic side effects by vaccines
Date of disclosure of the study information 2014/02/03
Last modified on 2019/08/16 11:52:50

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Basic information

Public title

Clinical study using samples of patients experienced systemic side effects by vaccines

Acronym

Clinical study using samples of patients experienced systemic side effects by vaccines

Scientific Title

Clinical study using samples of patients experienced systemic side effects by vaccines

Scientific Title:Acronym

Clinical study using samples of patients experienced systemic side effects by vaccines

Region

Japan


Condition

Condition

systemic side effects by vaccines

Classification by specialty

Clinical immunology Infectious disease

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Objectives of this study are to search the mechanism of side effect related vaccines.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

This study measures microRNA and mRNA by chip analysis, and also measures antibodies, cytokines and chemokines by ELISA.

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Those who are experienced systemic side effect of vaccine, and who agree to participate this study

Key exclusion criteria

Not obtained the consent

Target sample size

2


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ken Ishii

Organization

National Institutes of Biomedical Innovation,Health and Nutrition

Division name

Laboratory of Adjuvant Innovation

Zip code


Address

7-6-8 Asagi Saito Ibaraki-City Osaka

TEL

072-641-8043

Email

kenishii@biken.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ken Ishii

Organization

National Institutes of Biomedical Innovation,Health and Nutrition

Division name

Laboratory of Adjuvant Innovation

Zip code


Address

7-6-8 Asagi Saito Ibaraki-City Osaka

TEL

072-641-8043

Homepage URL


Email

kenishii@biken.osaka-u.ac.jp


Sponsor or person

Institute

National Institutes of Biomedical Innovation,Health and Nutrition

Institute

Department

Personal name



Funding Source

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2014 Year 02 Month 03 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2013 Year 07 Month 24 Day

Date of IRB

2013 Year 08 Month 02 Day

Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

sample
Serum, plasma, cerebrospinal fluid, biopsy tissue sample

analysis
Analyze between clinical information including which kind of vaccine, and obtained dates of samples


Management information

Registered date

2014 Year 02 Month 03 Day

Last modified on

2019 Year 08 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015183


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name